The Federal Court of Canada has dismissed requests by AstraZeneca to prohibit the Canadian Ministry of Health from issuing a Notice of Compliance (NOC) for the regulatory applications of a generic version of esomeprazole submitted by Canadian-based generics company Apotex.

As a result the Canadian Minister of Health is now free to issue a NOC to Apotex before the expiration of Nexium's Canadian patents (between 2013 and 2019).

In Canada, when seeking prohibition of a NOC, the court does not rule on the validity of patents, plus the ruling relates to only one of Nexium's Canadian patents. Therefore AstraZeneca’s options include launching a patent infringement action.

The UK-based company stated that it “will continue to vigorously defend its intellectual property for Nexium”, adding that “after receiving the court's decision, Apotex must obtain a NOC or regulatory approval from the Minister of Health before being able to launch a generic esomeprazole product in Canada”.

Any launch prior to patent expiry would be at risk of patent infringement action by AstraZeneca. It said it has many patents protecting Nexium in Canada, where sales of the drug in 2009 totalled US$217 million.

This is not the first generic to challenge AstraZeneca’s esomeprazole product. In December 2009, a Notice of Allegation was received from Mylan Pharmaceuticals, against which it issued proceedings in January 2010. Since 2008, AstraZeneca has also been embroiled in patent validity or infringement cases in Finland, Norway and Spain.

The epidemic of litigation is evidence of the money at stake if the generics start stealing market share from Nexium. Between the launch of esomeprazole in 2001 and 2005, the drug has netted AstraZeneca approximately US$14.4 billion.

Reference:

AstraZeneca Press release, Federal Court of Canada Rules on Applications for Generic Esomeprazole Magnesium, 17 June 2010